Metformin HCl

Product NDC: 50090-4891
11-digit product format: 500904891
Labeler code: 50090
Product ID: 50090-4891_fd7d0d68-c8fb-4f4b-88c4-8b3ad8e81e4e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin HCl
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA090564
Marketing category: ANDA
Marketing start: 2017-02-06
Substance: METFORMIN HYDROCHLORIDE
Active strength: 500 mg/1
Pharmacologic classes: Biguanide [EPC], Biguanides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090564-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22
A090564-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22
A090564-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A090564-001	AB
A090564-002	AB
A090564-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A090564-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090564-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090564-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 39 · 771 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	41408f64-d366-403e-9595-464ab25c6f97	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA078321 ndc (package): 72789-451-30 ndc (package): 72789-451-60 ndc (product): 72789-451 rxcui: 860981 spl id: 57d50f39-42f1-a5f9-e063-6294a90a220b spl set id: 41408f64-d366-403e-9595-464ab25c6f97 unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	68d0b1a6-c99e-42cf-afdf-b71ee73c4424	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA078321 ndc (package): 72789-454-93 ndc (package): 72789-454-60 ndc (package): 72789-454-90 ndc (product): 72789-454 rxcui: 860975 spl id: 57d55a41-fced-fd49-e063-6294a90a6ac7 spl set id: 68d0b1a6-c99e-42cf-afdf-b71ee73c4424 unii: 786Z46389E
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	9171d369-d35a-40e4-a9ad-26484e66fc5e	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA201991 ndc (package): 72789-400-93 ndc (package): 72789-400-60 ndc (package): 72789-400-86 ndc (package): 72789-400-82 ndc (package): 72789-400-90 ndc (package): 72789-400-01 ndc (product): 72789-400 rxcui: 860975 spl id: 57c3b035-7867-ce77-e063-6294a90aea84 spl set id: 9171d369-d35a-40e4-a9ad-26484e66fc5e unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	30658e19-8e6e-49aa-a007-e414224797c5	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564 ndc (package): 70518-2833-5 ndc (package): 70518-2833-9 ndc (package): 70518-2833-6 ndc (package): 70518-2833-1 ndc (package): 70518-2833-3 ndc (package): 70518-2833-7 ndc (package): 70518-2833-2 ndc (package): 70518-2833-8 ndc (package): 70518-2833-4 ndc (package): 70518-2833-0 ndc (product): 70518-2833 rxcui: 861007 spl id: 57c46cc3-ef60-bbf1-e063-6294a90a73ac spl set id: 30658e19-8e6e-49aa-a007-e414224797c5 unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	1503bbe4-0ac5-479b-9900-d38e49236bf0	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA078321 ndc (package): 70518-2709-1 ndc (package): 70518-2709-0 ndc (product): 70518-2709 spl id: 57ad2acc-273f-39f2-e063-6294a90a118e spl set id: 1503bbe4-0ac5-479b-9900-d38e49236bf0 unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	e22a8545-86a6-439e-a758-29c4d6ed8bfe	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA209694 ndc (package): 70518-4710-1 ndc (package): 70518-4710-0 ndc (product): 70518-4710 spl id: 57ae80ca-b1b2-d40e-e063-6294a90aa303 spl set id: e22a8545-86a6-439e-a758-29c4d6ed8bfe unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Cardinal Health 107, LLC	46cb7e3f-c739-433d-9dbe-427c2d95bef1	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564 ndc (package): 55154-4172-0 ndc (product): 55154-4172 rxcui: 861007 spl id: c3c024ed-5f95-4247-ab2f-38439c355d00 spl set id: 46cb7e3f-c739-433d-9dbe-427c2d95bef1 unii: 786Z46389E
Glucotrol XL	GLIPIZIDE	Roerig	eed99b60-d043-4249-9b2a-f05e46fb588d	2026-07-21	Warnings, Adverse reactions	Exact identifier unii: X7WDT95N5C
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Chartwell RX, LLC	4d3dbf6f-1c8a-4daa-8343-8cd8f64a65cd	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA075972 ndc (package): 62135-684-10 ndc (package): 62135-683-30 ndc (package): 62135-681-90 ndc (package): 62135-683-05 ndc (package): 62135-682-05 ndc (package): 62135-680-05 ndc (package): 62135-684-05 ndc (package): 62135-684-60 ndc (package): 62135-682-90 ndc (package): 62135-684-18 ndc (package): 62135-681-30 ndc (package): 62135-680-18 ndc (package): 62135-680-90 ndc (package): 62135-683-90 ndc (package): 62135-680-60 ndc (package): 62135-683-10 ndc (package): 62135-682-30 ndc (package): 62135-680-10 ndc (package): 62135-681-05 ndc (package): 62135-683-18 ndc (package): 62135-684-90 ndc (product): 62135-683 ndc (product): 62135-682 ndc (product): 62135-684 ndc (product): 62135-681 ndc (product): 62135-680 rxcui: 2703582 rxcui: 861021 rxcui: 861007 rxcui: 861010 rxcui: 861004 spl id: 570c5a61-a145-01f8-e063-6394a90acba5 spl set id: 4d3dbf6f-1c8a-4daa-8343-8cd8f64a65cd unii: 786Z46389E
Dapagliflozin	DAPAGLIFLOZIN	Aurobindo Pharma Limited	f56593f7-588e-489d-9fad-b459e90dab18	2026-07-17	Warnings, Adverse reactions	Exact identifier unii: 1ULL0QJ8UC
Metformin ER 500 mg	METFORMIN ER 500 MG	Granules India Ltd	b857eccf-b9ff-45ba-8241-f47f5caada2a	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA209313 ndc (package): 62207-491-31 ndc (package): 62207-492-43 ndc (package): 62207-492-49 ndc (package): 62207-492-47 ndc (package): 62207-492-40 ndc (package): 62207-492-74 ndc (package): 62207-491-47 ndc (package): 62207-491-49 ndc (package): 62207-491-35 ndc (package): 62207-492-54 ndc (package): 62207-491-54 ndc (package): 62207-491-43 ndc (product): 62207-492 ndc (product): 62207-491 rxcui: 860975 rxcui: 860981 spl id: 56cbdf81-acdf-940c-e063-6394a90ad166 spl set id: b857eccf-b9ff-45ba-8241-f47f5caada2a unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	13235d8e-ac3a-45b4-9c5d-9a9012951dfe	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA203769 ndc (package): 70518-1951-1 ndc (package): 70518-1951-2 ndc (package): 70518-1951-0 ndc (package): 70518-1951-3 ndc (product): 70518-1951 rxcui: 861007 spl id: 56bb1a29-eae4-eaf4-e063-6294a90a7aa7 spl set id: 13235d8e-ac3a-45b4-9c5d-9a9012951dfe unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	5aa1c86c-f2c8-49b1-8f81-47b11386c5d3	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564 ndc (package): 70518-4698-0 ndc (product): 70518-4698 rxcui: 861007 spl id: 56a5a4eb-f1b9-35f3-e063-6394a90a882a spl set id: 5aa1c86c-f2c8-49b1-8f81-47b11386c5d3 unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aurobindo Pharma Limited	4ac6d01a-af26-44e7-ae2e-3618de0080aa	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA077095 ndc (package): 65862-008-05 ndc (package): 65862-010-05 ndc (package): 65862-008-50 ndc (package): 65862-009-05 ndc (package): 65862-008-01 ndc (package): 65862-009-50 ndc (package): 65862-008-99 ndc (package): 65862-010-99 ndc (package): 65862-008-33 ndc (package): 65862-008-45 ndc (package): 65862-009-01 ndc (package): 65862-010-33 ndc (package): 65862-009-44 ndc (package): 65862-008-90 ndc (package): 65862-008-60 ndc (package): 65862-010-90 ndc (package): 65862-010-50 ndc (package): 65862-010-01 ndc (package): 65862-009-33 ndc (package): 65862-010-46 ndc (package): 65862-010-60 ndc (package): 65862-009-99 ndc (package): 65862-009-60 ndc (package): 65862-009-90 ndc (product): 65862-008 ndc (product): 65862-009 ndc (product): 65862-010 rxcui: 861007 rxcui: 861010 rxcui: 861004 spl id: 61f56acf-2add-4ee0-ad61-9dc5334cfc6a spl set id: 4ac6d01a-af26-44e7-ae2e-3618de0080aa unii: 786Z46389E
glyburide-metformin hydrochloride	GLYBURIDE-METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	b5ccf5da-cbe1-4009-ba1c-990050838ee9	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA079009 ndc (package): 71335-2508-4 ndc (package): 71335-2508-1 ndc (package): 71335-2508-5 ndc (package): 71335-2508-6 ndc (package): 71335-2508-3 ndc (package): 71335-2508-7 ndc (package): 71335-2508-8 ndc (product): 71335-2508 rxcui: 861753 spl id: 95ebc80a-0b2b-49f7-97bf-329187b3b45b spl set id: b5ccf5da-cbe1-4009-ba1c-990050838ee9 unii: 786Z46389E unii: SX6K58TVWC
glyburide-metformin hydrochloride	GLYBURIDE-METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	a086cc29-cb5d-40d0-a57d-8e91f1aa9158	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA079009 ndc (package): 71335-2694-5 ndc (package): 71335-2694-3 ndc (package): 71335-2694-2 ndc (package): 71335-2694-1 ndc (package): 71335-2694-4 ndc (product): 71335-2694 rxcui: 861748 spl id: a112dbe1-3324-4e92-8d0f-7d0d3951c37d spl set id: a086cc29-cb5d-40d0-a57d-8e91f1aa9158 unii: 786Z46389E unii: SX6K58TVWC
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	03151cb5-d32b-4484-8f2a-8c5d24c7f6f1	2026-07-14	Warnings, Adverse reactions	Exact identifier unii: X7WDT95N5C
Metformin HCl	METFORMIN HCL	PD-Rx Pharmaceuticals, Inc.	fb890205-5d43-41eb-97b2-fb0dcdd3a950	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564 ndc (package): 72789-192-30 ndc (package): 72789-192-21 ndc (package): 72789-192-93 ndc (package): 72789-192-60 ndc (package): 72789-192-20 ndc (product): 72789-192 rxcui: 861007 spl id: 5683dd49-29a1-2b76-e063-6294a90a3c5b spl set id: fb890205-5d43-41eb-97b2-fb0dcdd3a950 unii: 786Z46389E
JANUMET	SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	A-S Medication Solutions	c603b844-2019-4ef4-8385-7bc3f96a2565	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: NDA022044 ndc (package): 50090-5502-0 ndc (package): 50090-5502-1 ndc (product): 50090-5502 rxcui: 2709488 rxcui: 861771 spl id: e60a2c11-c521-495d-bc7c-10612ea7b2fa spl set id: c603b844-2019-4ef4-8385-7bc3f96a2565 unii: TS63EW8X6F unii: 786Z46389E
Glipizide	GLIPIZIDE	ANI Pharmaceuticals, Inc.	252ba4e0-8dc3-43e3-be00-32570dc095bd	2026-07-13	Warnings, Adverse reactions	Exact identifier unii: X7WDT95N5C

Additional Listing Data#

Finished product: Yes
Brand name base: Metformin HCl
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METFORMIN HYDROCHLORIDE	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
786Z46389E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
861007	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
74f18a3e-0f5c-4172-b499-14f229b431c4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6a29d87d-f465-752d-5fa9-bd728c608ca2	Product name	4	20251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698e	Product name	1	20250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5	Product name	7	20250515
25bfaa4d-02a1-402c-96ec-9bf6e625484c	Product name	1	20250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0	Product name	2	20240829
16dbe107-66d5-47b3-57ed-0cba6a8dfccc	Product name	6	20240215
08b3e508-8c7e-3b95-0275-113510642fc6	Product name	2	20220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8	Product name	1	20200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86	Product name	1	20200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5	Product name	1	20190731
ca3f036c-6c06-b829-b379-1a3a4097099c	Product name	9	20180605
e1ede89f-54c8-428f-ae84-9e8a2deb67db	Product name	1	20180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52c	Product name	2	20170824
bea938a6-c880-985b-d27b-b59b0d8b5a77	Product name	3	20170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2f	Product name	1	20170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cb	Product name	1	20170224
988f737f-e7e9-4613-8558-824b1ab755f9	Product name	1	20161128
58b66776-50d5-434f-916f-958ccf131e0e	Product name	1	20160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934	Product name	2	20151109
2988466d-5fc4-4430-9cee-fc9132f02d2c	Product name	1	20150910
85cbb42f-1a8d-f945-f85e-188e823b7f5b	Product name	2	20150731
e740bf83-275a-4f0c-adf4-ec60ebd882b7	Product name	1	20150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0	Product name	1	20141205
0d79b284-47e8-e90c-f249-892b9b251003	Product name	1	20140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6	Product name	1	20140508
2de6e143-c970-2061-1b77-61c3aa8f4026	Product name	1	20140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776a	Product name	1	20140508
ce63c1f8-ba50-8a17-9290-94522d75daff	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4891-0	2023-02-07	C162847	48780-1	f386c649-bb58-0266-e053-dadaa90a7c1a	Metformin Hydrochloride Tablets USP
50090-4891-0	2023-01-30	C162847	48780-1	f386c649-bb58-0266-e053-dadaa90a7c1a	Metformin Hydrochloride Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4891-0	Metformin HCl	90 in 1 BOTTLE	TABLET	90		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4891-0	EA - Each	50090-4891	2e7f9e00-ca5c-40cf-9b76-cb807736ef26	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4891	METFORMIN HCL TABLET [A-S MEDICATION SOLUTIONS]	5	Current NDC, Legacy NDC, 1 package rows	20230911_74f18a3e-0f5c-4172-b499-14f229b431c4.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861007	metFORMIN HCl 500 MG Oral Tablet	PSN	74f18a3e-0f5c-4172-b499-14f229b431c4	5
861007	metformin hydrochloride 500 MG Oral Tablet	SCD	74f18a3e-0f5c-4172-b499-14f229b431c4	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4891-0	50090489100	90 TABLET in 1 BOTTLE (50090-4891-0)	90 tablet	2020-02-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metformin Hydrochloride Tablets USP	A-S Medication Solutions	2023-09-10	Human Prescription Drug Label	5